Engineer, Quality

Job Title: Engineer, Quality Assurance

Reports To: Manager, Quality or Sr. Manager, QA/RA

Position Location: Buffalo, NY

FLSA Status (Exempt/Non-Exempt): Exempt

Position Summary:

The Quality Assurance Engineer is responsible for supporting and maintaining the Quality Management System (QMS) to ensure compliance with all applicable regulatory requirements, including but not limited to ISO 13485 and 21 CFR Part 820. The Quality Assurance Engineer partners cross-functionally with R&D, Manufacturing, and Regulatory Affairs to ensure product quality and compliance throughout the product lifecycle, from design and development through commercialization.

Key Responsibilities:

• Support and maintain the Quality Management System (QMS) in compliance with FDA, ISO 13485, CMDR and TGA requirements.
• Participate in design control activities, including Design and Development File documentation and design reviews.
• Participate in CAPA investigations, including performing root cause analysis and implementation of corrective and preventive actions.
• Conduct risk management activities in accordance with ISO 14971.
• Perform the intake, assessment, investigation and resolution of customer complaints.
• Support process, software and equipment validation activities (IQ/OQ/PQ) and ensure proper documentation.
• Support internal and external audits (FDA, notified bodies, and customers).
• Review and approve change controls, deviations, and nonconformance reports.
• Collaborate with manufacturing to address quality issues and improve processes.
• Support supplier quality activities, including supplier qualification and monitoring.
• Provide guidance and training to employees on quality standards, processes, and regulations to enhance overall awareness and adherence to quality requirements.
• Analyze quality data and metrics to identify trends and drive continuous improvement.

• Performs other duties as assigned.

Education:

• Bachelor’s Degree in Engineering, Life Sciences or related field.

Experience:

• 3-5+ years’ experience in Quality in GMP environment.

Preferred Qualifications:

• ASQ Certified Quality Engineer (CQE) or similar certification.
• Experience with regulatory submissions (510(k), CE Marking) is a plus.
• Experience with eQMS systems (e.g., MasterControl).
• Experience with risk management (ISO 14971) and validation activities.

Minimum Requirements/Qualifications:

• Working knowledge of current FDA, ISO 13485, CMDR and TGA medical device regulations.
• Ability to respond to internal and external quality audits and perform root cause analysis and risk assessment activities.
• Proficiency with Microsoft Office software (e.g. Microsoft Word, PowerPoint, Excel).
• Excellent technical writing and organizational skills.
• Familiarity with design controls and product lifecycle management.
• Strong analytical, problem-solving, and communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization.
• Strong work ethic and an ability to excel within a rapidly changing and growing organization.
• Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints.

What We Offer:

• Salary Range: $70,0000-$85,000, depending on location, experience, and qualifications.
• Benefits coverage begins day one, including the following:
  • Medical, Dental, Vision Insurance
  • Disability Insurance
  • Life Insurance
  • 401(k) company match
  • Paid Time Off (15 days annually)
  • Paid Holiday time (10 company-designated days)
  • Tuition Assistance
  • Additional benefits available with company package